1.
Spasticity. Rolling Meadows (IL): American Association of Neurological Surgeons; 2018: http://www​.aans.org/Patients​/Neurosurgical-Conditions-and-Treatments/Spasticity. Accessed 2018 May 10.
2.
Rosenbaum P, Paneth N, Leviton A, et al. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007;109:8–14. [PubMed: 17370477]
3.
Morris C. Definition and classification of cerebral palsy: a historical perspective. Dev Med Child Neurol Suppl. 2007;109:3–7. [PubMed: 17370476]
4.
Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013;55(6):509–519. [PubMed: 23346889]
5.
Robertson CMT, Ricci MF, O’Grady K, et al. Prevalence estimate of cerebral palsy in Northern Alberta: Births, 2008-2010. Can J Neurol Sci. 2017;44(4):366–374. [PubMed: 28322177]
6.
Koman LA, Paterson Smith B, Balkrishnan R. Spasticity associated with cerebral palsy in children: guidelines for the use of botulinum A toxin. Paediatr Drugs. 2003;5(1):11–23. [PubMed: 12513103]
7.
Oskoui M, Majnemer A, Dagenais L, Shevell MI. The relationship between gross motor function and manual ability in cerebral palsy. J Child Neurol. 2013;28(12):1646–1652. [PubMed: 23112248]
8.
CDR submission: Dysport Therapeutic (abobotulinumtoxinA), single-use sterile 500 Unit vial and 300 Unit vial. Company: Ipsen Biopharmaceuticals Canada Inc [CONFIDENTIAL manufacturer’s submission]. Mississauga (ON): Ipsen Biopharmaceuticals Canada Inc; Feb 2018.
9.
Syed YY. AbobotulinumtoxinA: A Review in pediatric lower limb spasticity. Paediatr Drugs. 2017;19(4):367–373. [PubMed: 28623614]
10.
Graham HK, Aoki KR, Autti-Ramo I, et al. Recommendations for the use of botulinum toxin type A in the management of cerebral palsy. Gait Posture. 2000;11(1):67–79. [PubMed: 10664488]
11.
Strobl W, Theologis T, Brunner R, et al. Best clinical practice in botulinum toxin treatment for children with cerebral palsy. Toxins (Basel). 2015;7(5):1629–1648. [PMC free article: PMC4448165] [PubMed: 25969944]
12.
Gorter JW, Verschuren O, van Riel L, Ketelaar M. The relationship between spasticity in young children (18 months of age) with cerebral palsy and their gross motor function development. BMC Musculoskelet Disord. 2009;10:108. [PMC free article: PMC2751738] [PubMed: 19728891]
13.
Jaspers E, Verhaegen A, Geens F, Van Campenhout A, Desloovere K, Molenaers G. Lower limb functioning and its impact on quality of life in ambulatory children with cerebral palsy. Eur J Paediatr Neurol. 2013;17(6):561–567. [PubMed: 23755939]
14.
Kim WH, Park EY. Causal relation between spasticity, strength, gross motor function, and functional outcome in children with cerebral palsy: a path analysis. Dev Med Child Neurol. 2011;53(1):68–73. [PubMed: 21126242]
15.
Ohata K, Tsuboyama T, Haruta T, Ichihashi N, Kato T, Nakamura T. Relation between muscle thickness, spasticity, and activity limitations in children and adolescents with cerebral palsy. Dev Med Child Neurol. 2008;50(2):152–156. [PubMed: 18201305]
16.
Delgado MR, Hirtz D, Aisen M, et al. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2010;74(4):336–343. [PMC free article: PMC3122302] [PubMed: 20101040]
17.
Dysport Therapeutic (abobotulinumtoxinA): 300 and 500 Units per vial sterile lyophilized powder for solution for injection [product monograph]. Mississauga (ON): Ipsen Biopharmaceuticals Canada Inc.; June 21 2018.
18.
PrBotox® (onabotulinumtoxinA for injection Ph.Eur., Clostridium botulinum type A neurotoxin complex (900kD)): 50, 100 and 200 Allergan units per vial [product monograph]. Markham (ON): Allergan, Inc.; Mar 01 2017.
19.
Satkunam LE. Rehabilitation medicine: 3. Management of adult spasticity. CMAJ. 2003;169(11):1173–1179. [PMC free article: PMC264959] [PubMed: 14638654]
20.
Heinen F, Desloovere K, Schroeder AS, et al. The updated European Consensus 2009 on the use of Botulinum toxin for children with cerebral palsy. Eur J Paediatr Neurol. 2010;14(1):45–66. [PubMed: 19914110]
21.
Novak I, McIntyre S, Morgan C, et al. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013;55(10):885–910. [PubMed: 23962350]
22.
Clinical Study Report: Y-55-52120-141. A phase III, multicentre, double blind, prospective, randomised, placebo controlled study assessing the efficacy and safety of Dysport used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy [CONFIDENTIAL internal manufacturer’s report]. Boulogne-Billancourt, France: Ipsen Pharma SAS; 2015.
23.
Delgado MR, Tilton A, Russman B, et al. AbobotulinumtoxinA for equinus foot deformity in cerebral palsy: A randomized controlled trial. Pediatrics. 2016;137(2):e20152830. [PubMed: 26812925]
24.
Kanovsky P, Bares M, Severa S, et al. Functional benefit of botulinum toxin (Dysport) in the treatment of dynamic equinus cerebral palsy spasticity: A prospective, multicentre, double-blind, placebo-controlled study. Ceska a Slovenska Neurologie a Neurochirurgie. 2004;67(1):16–23.
25.
Medical review(s). Dysport (abobotulinumtoxinA). Company: Ipsen Application no.: 125274/105. Approval date: 07/08/2016. Rockville (MD): FDA, Center for Drug Evaluation Research; 2016:
26.
Statistical review(s). Dysport (abobotulinumtoxinA). Company: Ipsen Application no.: 125274/105. Approval date: 07/08/2016. Rockville (MD): FDA, Center for Drug Evaluation Research; 2016:
27.
Health Canada reviewer’s report: Dysport Therapeutic (abobotulinum toxin type A) [CONFIDENTIAL internal report]. Ottawa: Therapeutics Products Directorate, Health Canada; [date unknown].
28.
Tilton A, Russman B, Aydin R, et al. AbobotulinumtoxinA (Dysport) improves function according to goal attainment in children with dynamic equinus due to cerebral palsy. J Child Neurol. 2017;32(5):482–487. [PMC free article: PMC5405835] [PubMed: 28068857]
29.
Dabrowski E, Bonikowski M, Gormley M, Volteau M, Picaut P, Delgado MR. AbobotulinumtoxinA efficacy and safety in children with equinus foot previously treated with botulinum toxin. Pediatr Neurol. 2018. [PubMed: 29625849]
30.
Clinical Study Report: Y-97-52120-701. A double-blind, prospective, randomised, placebo-controlled study to assess the efficacy and safety of DYSPORT® (30 units/kg) in the treatment of paediatric dynamic equinus spasticity associated with cerebral palsy [CONFIDENTIAL internal manufacturer’s report]. Berkshire [UK]: Beaufour Ipsen Group; 2000.
31.
Meseguer-Henarejos AB, Sanchez-Meca J, Lopez-Pina JA, Carles-Hernandez R. Inter- and intra-rater reliability of the Modified Ashworth Scale: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2017;13:13. [PubMed: 28901119]
32.
Biering-Sorensen F, Nielsen JB, Klinge K. Spasticity-assessment: a review. Spinal Cord. 2006;44(12):708–722. [PubMed: 16636687]
33.
Bohannon RW, Smith MB. Interrater reliability of a Modified Ashworth Scale of muscle spasticity. Phys Ther. 1987;67(2):206–207. [PubMed: 3809245]
34.
Mutlu A, Livanelioglu A, Gunel MK. Reliability of Ashworth and Modified Ashworth scales in children with spastic cerebral palsy. BMC Musculoskelet Disord. 2008;9:44. [PMC free article: PMC2330046] [PubMed: 18402701]
35.
Clopton N, Dutton J, Featherston T, Grigsby A, Mobley J, Melvin J. Interrater and intrarater reliability of the Modified Ashworth Scale in children with hypertonia. Pediatr Phys Ther. 2005;17(4):268–274. [PubMed: 16357682]
36.
Fosang AL, Galea MP, McCoy AT, Reddihough DS, Story I. Measures of muscle and joint performance in the lower limb of children with cerebral palsy. Dev Med Child Neurol. 2003;45(10):664–670. [PubMed: 14515937]
37.
Kiresuk TJ, Sherman RE. Goal attainment scaling: A general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968;4(6):443–453. [PubMed: 24185570]
38.
Turner-Stokes L, Baguley IJ, De Graaff S, et al. Goal attainment scaling in the evaluation of treatment of upper limb spasticity with botulinum toxin: a secondary analysis from a double-blind placebo-controlled randomized clinical trial. J Rehabil Med. 2010;42(1):81–89. [PubMed: 20111849]
39.
Cusick A, McIntyre S, Novak I, Lannin N, Lowe K. A comparison of goal attainment scaling and the Canadian Occupational Performance Measure for paediatric rehabilitation research. Pediatr Rehabil. 2006;9(2):149–157. [PubMed: 16449074]
40.
Ashford S, Turner-Stokes L. Goal attainment for spasticity management using botulinum toxin. Physiother Res Int. 2006;11(1):24–34. [PubMed: 16594313]
41.
Gracies JM, Burke K, Clegg NJ, et al. Reliability of the Tardieu Scale for assessing spasticity in children with cerebral palsy. Arch Phys Med Rehabil. 2010;91(3):421–428. [PubMed: 20298834]
42.
Haugh AB, Pandyan AD, Johnson GR. A systematic review of the Tardieu Scale for the measurement of spasticity. Disabil Rehabil. 2006;28(15):899–907. [PubMed: 16861197]
43.
Mackey AH, Lobb GL, Walt SE, Stott NS. Reliability and validity of the Observational Gait Scale in children with spastic diplegia. Dev Med Child Neurol. 2003;45(1):4–11. [PubMed: 12549749]
44.
Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999;37(2):126–139. [PubMed: 10024117]
45.
Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001;39(8):800–812. [PubMed: 11468499]
46.
Bieri D, Reeve RA, Champion GD, Addicoat L, Ziegler JB. The Faces Pain Scale for the self-assessment of the severity of pain experienced by children: development, initial validation, and preliminary investigation for ratio scale properties. Pain. 1990;41(2):139–150. [PubMed: 2367140]
47.
Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001;93(2):173–183. [PubMed: 11427329]
48.
Lundkvist Josenby A, Jarnlo GB, Gummesson C, Nordmark E. Longitudinal construct validity of the GMFM-88 total score and goal total score and the GMFM-66 score in a 5-year follow-up study. Phys Ther. 2009;89(4):342–350. [PubMed: 19220999]
49.
Bjornson K. Validity of the Gross Motor Function Measure. Pediatr Phys Ther. 10:43–47.
50.
Russell DJ, Rosenbaum PL, Cadman DT, Gowland C, Hardy S, Jarvis S. The gross motor function measure: a means to evaluate the effects of physical therapy. Dev Med Child Neurol. 1989;31(3):341–352. [PubMed: 2753238]
51.
Clinical Study Report: Y-55-52120-147. A phase III, prospective, multicentre, open label, extension study assessing the long term safety and efficacy of repeated treatment with Dysport used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy [CONFIDENTIAL internal manufacturer’s report]. Boulogne-Billancourt, France: Ipsen Pharma SAS; 2015.
52.
Wang Y, Gao B. A dose-response relationship research on botulinum toxin type A local intramuscular injections of lower extremity spasticity in children with cerebral palsy. Childs Nervous System. 2008;24(5):545–547. [PubMed: 18297290]
53.
Childers MK, Brashear A, Jozefczyk P, et al. Dose-dependent response to intramuscular botulinum toxin type A for upper-limb spasticity in patients after a stroke. Arch Phys Med Rehabil. 2004;85(7):1063–1069. [PubMed: 15241751]
54.
Numanoglu A, Gunel MK. Intraobserver reliability of modified Ashworth scale and modified Tardieu scale in the assessment of spasticity in children with cerebral palsy. Acta Orthop Traumatol Turc. 2012;46(3):196–200. [PubMed: 22659636]
55.
Yam WK, Leung MS. Interrater reliability of Modified Ashworth Scale and Modified Tardieu Scale in children with spastic cerebral palsy. J Child Neurol. 2006;21(12):1031–1035. [PubMed: 17156693]
56.
Varni JW, Seid M, Knight TS, Uzark K, Szer IS. The PedsQL 4.0 Generic Core Scales: sensitivity, responsiveness, and impact on clinical decision-making. J Behav Med. 2002;25(2):175–193. [PubMed: 11977437]
57.
Alhusaini AA, Dean CM, Crosbie J, Shepherd RB, Lewis J. Evaluation of spasticity in children with cerebral palsy using Ashworth and Tardieu Scales compared with laboratory measures. J Child Neurol. 2010;25(10):1242–1247. [PubMed: 20223745]
58.
Bar-On L, Aertbelien E, Molenaers G, et al. Instrumented assessment of the effect of Botulinum Toxin-A in the medial hamstrings in children with cerebral palsy. Gait Posture. 2014;39(1):17–22. [PubMed: 23791154]
59.
Modified Ashworth Scale. Ottawa: Canadian Partnership for Stroke Recovery; 2011: https://www​.strokengine​.ca/en/assess/mashs/. Accessed 2018 May 10.
60.
Varni JW, Burwinkle TM, Seid M. The PedsQL as a pediatric patient-reported outcome: reliability and validity of the PedsQL Measurement Model in 25,000 children. Expert Rev Pharmacoecon Outcomes Res. 2005;5(6):705–719. [PubMed: 19807613]
61.
Varni JW. PedsQL Measurement Model for the Pediatric Quality of Life Inventory. 2018; http://www​.pedsql.org/index.html. Accessed 2018 May 10.
62.
Desai AD, Zhou C, Stanford S, Haaland W, Varni JW, Mangione-Smith RM. Validity and responsiveness of the pediatric quality of life inventory (PedsQL) 4.0 generic core scales in the pediatric inpatient setting. JAMA pediatrics. 2014;168(12):1114–1121. [PubMed: 25347549]
63.
Delgado MR, Bonikowski M, Carranza J, et al. Safety and efficacy of repeat open-label abobotulinumtoxinA treatment in pediatric cerebral palsy. J Child Neurol. 2017;32(13):1058–1064. [PMC free article: PMC5652649] [PubMed: 28914131]
64.
A Systematic literature review and network meta-analysis of the clinical efficacy and safety of treatment options for children with spasticity. 2017. In: CDR submission: Dysport Therapeutic (abobotulinumtoxinA), single-use sterile 500 Unit vial and 300 Unit vial. Company: Ipsen Biopharmaceuticals Canada Inc. [CONFIDENTIAL manufacturer’s submission]
65.
Ackman JD, Russman BS, Thomas SS, et al. Comparing botulinum toxin A with casting for treatment of dynamic equinus in children with cerebral palsy. Dev Med Child Neurol. 2005;47(9):620–627. [PubMed: 16138670]
66.
Kay RM, Rethlefsen SA, Fern-Buneo A, Wren TA, Skaggs DL. Botulinum toxin as an adjunct to serial casting treatment in children with cerebral palsy. Journal of Bone & Joint Surgery - American Volume. 2004;86-A(11):2377–2384. [PubMed: 15523006]
67.
Love SC, Valentine JP, Blair EM, Price CJ, Cole JH, Chauvel PJ. The effect of botulinum toxin type A on the functional ability of the child with spastic hemiplegia a randomized controlled trial. Eur J Neurol. 2001;8 Suppl 5:50–58. [PubMed: 11851734]
68.
Copeland L, Edwards P, Thorley M, et al. Botulinum toxin A for nonambulatory children with cerebral palsy: a double blind randomized controlled trial. J Pediatr. 2014;165(1):140–146.e144. [PubMed: 24630348]
69.
Mall V, Heinen F, Siebel A, et al. Treatment of adductor spasticity with BTX-A in children with CP: a randomized, double-blind, placebo-controlled study. Dev Med Child Neurol. 2006;48(1):10–13. [PubMed: 16359588]
70.
Ubhi T, Bhakta BB, Ives HL, Allgar V, Roussounis SH. Randomised double blind placebo controlled trial of the effect of botulinum toxin on walking in cerebral palsy. Arch Dis Child. 2000;83(6):481–487. [PMC free article: PMC1718586] [PubMed: 11087280]
71.
Zhu DN, Wang MM, Wang J, et al. [Effect of botulinum toxin A injection in the treatment of gastrocnemius spasticity in children aged 9-36 months with cerebral palsy: a prospective study]. Zhongguo Dangdai Erke Zazhi. 2016;18(2):123–129. [PMC free article: PMC7403036] [PubMed: 26903058]
72.
Koman LA, Mooney JF, 3rd, Smith BP, Walker F, Leon JM. Botulinum toxin type A neuromuscular blockade in the treatment of lower extremity spasticity in cerebral palsy: a randomized, double-blind, placebo-controlled trial. BOTOX Study Group. J Pediatr Orthop. 2000;20(1):108–115. [PubMed: 10641699]
73.
Bjornson K, Hays R, Graubert C, et al. Botulinum toxin for spasticity in children with cerebral palsy: a comprehensive evaluation. Pediatrics. 2007;120(1):49–58. [PMC free article: PMC1920182] [PubMed: 17606561]
74.
Dias S, Welton NJ, Sutton AJ, Ades AE. A Generalised Linear Modelling Framework for Pairwise and Network Meta-Analysis of Randomised Controlled Trials. 2014. In: NICE Decision Support Unit Technical Support Documents. London: National Institute for Health and Care Excellence (NICE) [PubMed: 27466657]